Transcript OnSite Leishmania Ab Rapid Test (Strip) Leishmania IgG / IgM Rapid Test A Leading Product On Market by Using CTK Licensed Patented Antigen Visceral.

OnSite
Leishmania Ab Rapid Test (Strip)
Leishmania IgG / IgM Rapid Test
A Leading Product On Market by Using CTK Licensed Patented Antigen
Visceral Leishmaniasis (VL)
• 300,000 new cases and over
20,000 deaths annually
• 90% in：
o Indian subcontinent, such as
Bangladesh, India, Nepal
o Sudan
o Ethiopia
o Brazil
• Transmitted by the sandfly
Clinical Feature of V. Leishmaniasis
• Fever
• Weight loss
• Affects spleen, liver, and bone marrow
• Nearly always Fatal if not treated
Diagnostic Methods of V. Leishimaniasis
*DAT: Direct Agglutination Test **IFA: Immunofluorescence Assay
Methods
Specimen
Test Time
Remarks
Microscopy
detects amastigote
Splenic aspirate,
liver biopsy or
bone marrow
biopsy
≥ 30 min
• Invasive procedure to obtain specimen
• Requires skilled technician
• Accuracy depends on the microscopist
• Amastigotes may be scant and difficult to view
Culture
detects amastigote
Splenic aspirate,
bone marrow
biopsy
10-21 days
• Invasive procedure to obtain specimen
• Undetectable since the amastigote stage can
transform into the promastigote stage
DAT*
Serum, plasma
Over night
• Dilute specimens prior to assaying
• Need microtitration plates & incubator
• Slight variations in reading result
IFA**
Serum, plasma
≥ 1 hour
• Dilute specimen prior to assaying
• Requires fluorescence microscope
• Cross reacts with Trypanosoma cruzi
ELISA
Serum, plasma
≥ 1 hour
• Trained technician
• Requires incubator and ELISA reader
• IgG/IgM tested separately
Rapid
Tests
Serum, plasma,
whole blood
15 min
• No equipment required
• Minimal training
• Irrespective of parasite stage
Serodiagnosis
detects Ab
Rapid Test is the simplest diagnostic method
OnSite Leishmania Rapid Test kits
Two Formats Meet Different Needs
OnSite Leishmania Ab Rapid Test
• Strip
• Serum/Plasma
• Detect Abs
• Cost effective
STRAEGIC PARTNER
OnSite Leishmania IgG/IgM Rapid Test
• Cassette
• Serum/Plasma/Whole Blood
• Detect and differentiate IgG and IgM
• High accuracy
OnSite Leishmania Rapid Test kits
Utilize rK39 for Better Performance
CTK Licensed patented rK39 antigen from IDRI to make the product
• With excellent performance
• More sensitive than rKE16 based product
• WHO qualified
OnSite Leishmania Ab Rapid Test (strip)
Simple Procedure, Fast Result, Cost Effective
Catalog # R0122S
Intended use
Qualitatively detects anti-VL
by using rk39 antigen
Specimen type
Serum/Plasma
Reading time
15 minutes
Equipments
No
Training
minimal
Shelf life
18 months
Package size
50 tests
Control line
Test line
OnSite Leishmania Ab Rapid Test (strip)
Simple, Rapid Procedure
5 μL of specimen
2 drops of sample diluent
15 minutes
OnSite Leishmania Ab Rapid Test (strip)
Clear, Easy-To-Read Result
Negative
Only C line is developed
Positive
Both C and T line are developed
Invalid
No C line is developed
OnSite Leishmania Ab Rapid Test (strip)
Excellent Performance Comparing To Competitor
● A total 200 samples from susceptible subjects were tested by the
OnSite Leishmania Ab Rapid Test and by a reference Kalazar Ab rapid
test
Reference
Positive
Negative
Total
OnSite Leishmania Ab Rapid Test
Positive
Negative
31
0
0
169
31
169
Total
31
169
200
Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100%
OnSite Leishmania Ab Rapid Test (strip)
Leading Product On Market
• WHO evaluation series
• Sensitivity, specificity and reproducibility
Parameter
Sensitivity
(n=250)
Specificity
(n=249)
Average Score
(Highest 18)
OnSite
99.6%
(97.8-99.9%)
96.8%
(93.8-98.4%)
13.5
Participant A
92.8%
(88.9-95.4%)
99.2%
(97.1-99.8%)
9.9
Participant B
98.8%
(96.5-99.6%)
97.6%
(94.8-98.9%)
11.0
Participant C
99.6%
(97.8-99.9%)
96.0%
(92.8-97.8%)
11.8
Participant D
100%
(97.9-100%)
100%
(97.8-100%)
10.9
OnSite Leishmania Ab Rapid Test (strip)
Leading Product on Market
• WHO evaluation series
• Heat Stable
Parameter
OnSite
Participant A
Participant B
Participant C
Proportion positive
results among cases
(n=20)
4℃
37℃
45℃
100% 100% 100%
95%
90%
90%
100% 100%
0%
100% 100% 100%
Proportion Negative
results among cases
(n=4)
4℃
37℃ 45℃
100% 100% 100%
100% 100% 100%
100% 100% 100%
100% 100% 100%
Proportion Invalid
results
(n=24)
4℃ 37℃ 45℃
0%
0%
0%
0%
0%
0%
0%
0% 100%
0%
0%
0%
OnSite Leishmania Rapid Test Kits
The Right Choice for You
• Non-invasive
• High accuracy
o sensitivity >99.6%
o specificity > 96.8%
• WHO qualified
o Average score: 13.5 (highest 18)
• Simple procedure, fast result with minimal training requirement
• Low cost
• Strip or cassette format, wide-ranging specimen (S/P/WB)
• More product available
o Leishmania Ab ELISA Kit
Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739
QUALITY . INNOVATION . SIMPLICITY